Recall Z-0489-2022 ยท PHX Shoulder Prosthesis, Reverse Configuration
DePuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
| Date | Dec 7, 2021 |
| Status | Terminated |
| Reason | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage |
| Root cause | Equipment maintenance |
| Action | DePuy notified US hospital / government consignees on 12/7/21 letter Urgent Medical Device Recall (Removal) via the sales consult and product will be removed/notice delivered by hand or if not able to enter facility the form will be emailed and returns will be arranged. US sales/distributor offices will be notified via email. Affiliates outside of the US affiliates will be notified via the electronic system and recall activities will be carried out per local regulations. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you |
| Quantity | 451 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom. |
| FDA record | Open on fda.gov |